NCT06104007

Brief Summary

The SFRGENISTA study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with coronary in-stent restenosis (ISR).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Aug 2023Dec 2028

Study Start

First participant enrolled

August 17, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

4.9 years

First QC Date

October 23, 2023

Last Update Submit

October 23, 2023

Conditions

Coronary Artery DiseaseIn-stent Restenosis

Keywords

Coronary Artery DiseaseIn-stent RestenosisDrug-coated Balloon

Outcome Measures

Primary Outcomes (1)

  • Target lesion failure

    A composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization

    1 year

Secondary Outcomes (10)

  • Major adverse cardiac event

    1 year

  • All-cause death

    1 year

  • Cardiac death

    1 year

  • Myocardial infarction

    1 year

  • Target vessel myocardial infarction

    1 year

  • +5 more secondary outcomes

Study Arms (1)

Genoss® DCB

Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB

Device: Genoss® DCB

Interventions

Genoss® DCBDEVICE

This study includes patients with coronary in-stent restenosis (ISR) who have undergone percutaneous coronary intervention (PCI) according to standard treatment protocols using the Genoss® DCB and have agreed to participate in the clinical research. The decision on which drug-coated balloon (DCB) to use during PCI is entirely based on the patient's condition and the characteristics of the coronary lesions identified through angiography. Thus, it's not possible to determine in advance to use the Genoss® DCB before the procedure, nor can the number of drug-coated balloon catheters to be used during the procedure be known or decided upon beforehand.

Genoss® DCB

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary in-stent restenosis who underwent percutaneous coronary intervention using the Genoss® DCB.

You may qualify if:

  • Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.
  • Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.

You may not qualify if:

  • Women of childbearing age who plan to become pregnant during the study duration.
  • Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.
  • Patients for whom the expected remaining life span is less than one year.
  • Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.
  • Patients currently involved in a randomized medical device study.
  • Patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bon-Kwon Koo

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

+82-2-2072-2062bkkoo@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

August 17, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

KR(1)